Events

Rappel de Device Recall Triad Alcohol Prep Pads

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Alere San Diego.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    59064
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2661-2011
  • Date de mise en oeuvre de l'événement
    2011-02-28
  • Date de publication de l'événement
    2011-06-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100988
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Test, time, prothrombin - Product Code GJS
  • Cause
    The recall of the triad group alcohol prep products is due to potential contamination of these products with the bacteria bacillus cereus, which could lead to life-threatening infections.
  • Action
    Alere sent a CUSTOMER NOTIFICATION letter on February 28, 2011 to all affected custumers. The letter included; description of product, affected lots, statement of potential for contamination which could lead to life-threatening infections. Alere asked its customers to discard the Triad Alcohol Prep Pads provided and complete and FAX the enclosed Verification Form within 10 days to confirm receipt of notice and to indicate the number of discarded/required replacement alcohol prep pads. The letter instructed customers to call Alere Technical Services for additional information at 888-246-7483.

Device

Device Recall Triad Alcohol Prep Pads
  • Modèle / numéro de série
    Lot/Unit Codes: Applicable to all INRatio kit lots packaged Triad Alcohol prep pads from 4/19/09 through 2/7/11, including the following:  218494,220447,223941,223943,224250,224251,224770,224771,224772,225544,229364,229365, 229366,229367,229368,229369,229370,229371,235188,235189,236334,236335,236336,238868, 238869,239283,239418,239419,239595,243020,243021,243413,243414,243415,243416,243417, 243418,243855,243856,243857,243858,243859,243860,243861,243862,243863,243864,243865, 244432,245759,245760,245761,245762,245763,245764
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--(USA) Nationwide and countries of Canada, Australia, Japan and Puerto Rico
  • Description du dispositif
    0200086, Triad Alcohol Prep Pads, 100 box || 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or || Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; || 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- || Test System; || 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit
  • Manufacturer
    Alere San Diego

Manufacturer

Alere San Diego
  • Adresse du fabricant
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA